Z-1616-2024 Class II Ongoing
FDA device recall Z-1616-2024 was initiated by EBI, LLC on March 22, 2024 and is designated Class II. Reason for recall: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of … The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- March 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
Reason for Recall
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 00812301020218 All devices distributed since May 1, 2023